Ascletis Pharma Selects ASC36 Oral Amylin Receptor Peptide Agonist for Clinical Development Targeting Obesity
Wednesday, February 11, 2026
Ascletis Pharma Inc., a leading biotechnology company focused on innovative therapeutics for metabolic diseases, has announced the selection of ASC36 oral tablets for clinical development. This milestone represents a significant advancement in the treatment of obesity, leveraging the company's proprietary technologies to deliver a novel oral peptide agonist targeting the amylin receptor.
ASC36 is the first oral amylin receptor peptide agonist developed by Ascletis, discovered and optimized using their Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) platform. The oral tablet formulation was enabled by the company's Peptide Oral Transport ENhancement Technology (POTENT), which facilitates the oral delivery of peptides—a challenging feat in pharmaceutical development. Preclinical data from non-human primates (NHPs) demonstrate compelling pharmacokinetics, with 10 mg doses achieving 8% absolute oral bioavailability and a steady-state elimination half-life of 116 hours, while 25 mg doses showed 6% bioavailability and 167 hours half-life. These properties support once-daily dosing with potential for less frequent administration, offering convenience for patients managing chronic obesity.
The decision to advance ASC36 follows rigorous internal evaluation and positions it as a key component of Ascletis' diversified pipeline in metabolic diseases. Dr. Jinzi Jason Wu, Founder, Chairman, and CEO of Ascletis, highlighted ASC36 as one of three strategic amylin drug candidates, alongside an oral small molecule amylin agonist and a once-monthly subcutaneous injectable peptide amylin. This multi-pronged approach, powered by proprietary platforms including AISBDD, Ultra-Long-Acting Platform (ULAP), and POTENT, underscores Ascletis' commitment to addressing unmet needs in obesity and related metabolic disorders through differentiated, best-in-class therapies.
Ascletis plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for ASC36 oral tablets in the second quarter of 2026, targeting obesity as the initial indication. This regulatory step marks the transition from preclinical to clinical stages, with potential implications for global markets, including Asia where metabolic diseases are rising rapidly due to lifestyle changes and aging populations. The company's Hong Kong Stock Exchange listing (1672.HK) provides a stable platform for further R&D investments and partnerships.
In the broader context of Asia's biopharma landscape, Ascletis' progress with ASC36 exemplifies the region's growing prowess in peptide therapeutics and oral delivery innovations. Obesity treatments, particularly GLP-1 and amylin agonists, have surged in demand following successes like semaglutide, creating opportunities for next-generation agents with improved profiles. Ascletis' pipeline also includes ASC30 (GLP-1R agonist), ASC35 (GLP-1R/GIPR dual agonist), and ASC37 (GLP-1R/GIPR/GCGR triple agonist), forming a comprehensive portfolio for chronic weight management.
This development aligns with strategic category focuses such as Research & Development and Bio Pharma, reinforcing Asia's role in global innovation. As clinical trials progress, ASC36 could offer a competitive edge through oral administration, potentially reducing injection-related barriers and enhancing patient adherence. Stakeholders in pharma manufacturing, clinical trials, and regulatory affairs will monitor closely, given the technology's transferability to other peptides. Ascletis' integrated model—from discovery to commercialization—positions it to capture market share in the burgeoning anti-obesity sector, projected to exceed tens of billions globally.
Further details on ASC36's mechanism involve mimicking amylin, a hormone co-secreted with insulin that regulates appetite and glucose homeostasis. By activating amylin receptors, ASC36 promotes satiety, slows gastric emptying, and supports sustained weight loss, complementing GLP-1 based therapies. Safety profiles from NHP studies were favorable, paving the way for human trials. Industry partners, including those in supply chain and IT for drug discovery, may find collaboration opportunities here. Overall, this announcement signals robust momentum in Asian biopharma R&D for metabolic innovations.
